Friday, October 30, 2009

Of the patients studied, 801 were taking statins anyway and continued taking them while hospitalized. Seventeen patients who were taking statins died while in the hospital or within a month afterward, compared to 64 who were not taking statins, Vandermeer said.

Overall, 2.1 percent of patients taking statins died, compared to 3.2 percent of patients not taking statins. That means patients taking statins were just under 50 percent less likely to die.

Turns out this is from a press release regarding reports being presented this weekend at the annual meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia, so while the data are intriguing, they are by no means conclusive.

I find it interesting that the Congressional Budget Office's House health care bill budget estimate was posted to four significant digits ($1.055 Trillion dollars) even though CBO Director Doug Elmendorf, in a Thursday letter to House Democratic Chairmen, cautioned that his estimates are preliminary and "subject to substantial uncertainty."

Why is that so?

Could it be that the "estimate" looks better as $1.055 trillion when reported in the press than $1.1 trillion?

I guess these days, what's a few hundred billion dollars among friends?

Wednesday, October 28, 2009

The girls of Girl Scout troop 6254 will literally and figuratively give away their hearts next weekend.

As part of the troop's "stress for less" badge project, the troop's 10 fifth graders have spent about six weeks cutting, stuffing and sewing heart-shaped pillows. But instead of sitting on living room sofas, the throw pillows will land in the arms of heart surgery patients at Scott and White Hospital in Temple.

Rachael Clift, one of three co-leaders of the troop, said the project was born when the troop came up with ways to be less stressed.

"One of them was to give to others because if you can focus on other people, sometimes that's helpful instead of concentrating on what you're stressed about," she said.

Each troop member gave individual attention to a pillow, picking different fabrics and making them different in little ways. When the pillows were done, however, each girl added the same touch to their individual pillows.

Letters, one pinned to each stuffed felt heart, carry words of encouragement for those who going through a grueling recovery process.

Tuesday, October 27, 2009

Under the pilot project, Medicare is saving 4.4% on the base rates for heart and joint surgeries at Hillcrest because the hospital is offering a discount. For Morrow's knee replacement, for example, the government is paying $13,211, about $450 less than it normally would.

Meanwhile, Morrow, who is eager to get back to playing basketball, gets a portion of the savings from Medicare — $271 as an incentive for going to a hospital that participates in the program.

The three-year experiment, which began in May, is taking place at five hospitals identified by Medicare for high-quality, cost-efficient care. All competed to get into the program by offering discounts to Medicare.

Besides Hillcrest, Baptist Health System in San Antonio is taking part, while hospitals in Denver, Albuquerque and Oklahoma City are expected to begin participating this year.

Patients who use the hospitals for most heart and orthopedic procedures are paid up to $1,157 for participating, with the bigger amounts pegged to more complicated cardiac surgeries, such as heart-valve replacements.

The incentive payment is supposed to help drive higher admissions to the hospitals in the program, and the pilot is designed to test whether paying Medicare beneficiaries from $250 to $1,157 sways their choice of facilities.

I can see it now: having a hard time paying your phone bill? Why, get your knee replaced!

A new Mayo Clinic study suggests that video capsule endoscopy (CE), a procedure that uses wireless technology in diagnosing intestinal disease, is safe for patients with heart devices. Wireless electrical gadgets, such as cell phones, have been shown to interfere with implanted heart devices, including pacemakers and defibrillators. This risk has led medical experts to speculate that capsule endoscopy could similarly cause heart devices to fail.

As a result, the noninvasive procedure has been contraindicated by the U.S. Food and Drug Administration (FDA) for patients with cardiac devices. Contraindication means an increased risk may be involved.

Generally, the topic has remained in the subject of speculation, although several small studies have found no interference with cardiac devices, and no clinical reports have surfaced linking CE to problems with them.

But these results might be rendered moot since Medicare has already rendered their opinion on whether they will pay for virtual pill colonoscopies:

Dr. (Barry) Straube's group touched off an uproar earlier this year with a decision that Medicare wouldn't pay for so-called virtual colonoscopies, which use medical imaging -- instead of inserting a tube into the colon -- to look for signs of abnormal growths. It cited insufficient scientific evidence that the procedure would benefit "average-risk Medicare beneficiaries."

Supporters, including oncologists and medical-imaging companies such as General Electric Co. and Siemens AG, say the less-invasive procedure saves lives. But some physician groups say the technique isn't cost effective -- a point Dr. Straube's group used in its decision-making, though it stated that "cost and cost effectiveness didn't greatly influence this decision."

Market forces today are causing more hospital systems to "affilitate" so they can share (pdf) management expertise to improve staffing efficiencies and purchasing power with lucrative medical device contracts.

I find it interesting that hospital systems and their administrators can move across state lines at will, but patients can't get similar leverage across state lines for their health insurance purchases.

Monday, October 26, 2009

Faced with the uncertainty over health care reform, the slumping economy, and the looming pay cuts to cardiologists, cardiology fellows are seeing one of the most challenging job markets in years. As a result, the number of e-mails we've received from fellows probing for potential job openings has accelerated to unprecedented levels.

For those who fear health care reform, fear not.

Before any bill has made it to the Congressional floor, certain aspects of health care reform are already here.

"Because unlike the emergency room, where care is transfered easily to guys arriving at the next shift, hospitalists don't have that luxury. We have to stick with our patients once they're ours.

Let's say it's quarter to five. The nocturnist comes on at six. The call comes from the ER and you get a guy that's sick as hell: something like an aortic dissection with crappy renal function that's too sick for surgery. He's never been in our system. No history. No real physical. The family doesn't know his medications. The ER only provides a listing - no doses - I have to call their home and get the list or wait for them to bring in the bottles, review the labs, order a slew more tests. I can't just offload the case to the evening nocturist at six - he's got his own ER admissions he has to see. Meanwhile, I still haven't written notes from seven other patients I've seen that day and have a slew of phone calls and results that I have to review. I can't just offload that to someone else..."

I give this great hospitalist about another month.

Good care takes time. Family social challenges, missing patient information, higher levels of disease severity and anxiety over patient's well-being add to physician stress. As larger number of patients are pushed through the system in shorter periods of time, physician burnout - even in the hospitalists "shift model" - remains a significant problem today.

Saturday, October 24, 2009

The legislation does not work like a sales or excise tax. Rather, it follows the model of the punitive tobacco settlement imposed on cigarette companies in the '90s. It assesses an industry-wide payment that firms must make in proportion to their market share. It bars the them from passing along the cost of the assessment by charging more for certain basic products, but allows them to raise the price of others to raise the funds for the fee.

The result will be that virtually every piece of advanced surgical equipment will be subject to a price increase to meet the levy from Washington. No matter that these devices often make the difference between life and death and that, in effect, taxing them raises the cost of vital treatments. The vengeful White House will have its pound of flesh from the medical device industry for daring to be independent and to refuse to knuckle down to administration pressure.

Part of the reason the device industry did not capitulate on the price consessions was that hospitals are already pressuring device companies to lower their prices. Despite their best efforts, medical device companies will continue to feel the pinch from increasingly capitated payments to "Accountable Care Organizations" (aka, big lumbering hospital systems serving as HMO's), we'll see the gradual erosion of medical innovation in favor of business survival, especially for those who don't "play nice" with reform efforts underway.

But rest assured, for those accustomed to doing business the "Chicago Way," they'll continue to see the government gravy train flowing their way.

Thursday, October 22, 2009

In an era where the medical device industry is increasingly concerned about health care reform, innovation, and the implications for providing their products to patients, it's nice to know there are helpful companies sprouting up that can place company literature about mechanical, biologic, or percutaneous prosthetic aortic valves, both approved and experimental, on your iPhone free of charge. Further, if you want to go ahead and calculate your own STS (Society of Thoracic Surgery) Risk Calculator for placement of a heart valve, heck, you can do that also.

Do not, however, look for objective criticism of the various valve types since most device literature there fails to include warnings, containdications, or adverse events about the devices. Further, references were not hyperlinked, making the utility of the quickly reviewing the references challenging for the casual user. Maybe more information is provided if you're a patient that registers for the $39.99 (doctors pay $59.99) annual access fee to become part of the "network," but I regret that I failed to cough up the change when I realized I could just search Google instead on my iPhone for the same information.

However, I did register as a "patient" as a free trial to look around, and saw some nicely-produced industry videos from YouTube for my consumption, information on some nice doctors with an interest in experimental percutaneous valve placements and thoracic surgery along with information on which insurers those doctors accept.

But a word of caution is also in order. The images and content I found on the iPhone app appear to be those also displayed on the manufacturers' websites and from doctor's available online webpages. Whether or not these doctors are aware that this information exists there is uncertain. I did a little investigative reporting and discovered that at least one of the doctors on the company website did not personally register his information nor grant permission for its use there. In short, then, the iMobileHealthCare team appears to have aggregated information from various web sources with a heavy bias toward percutaneous aortic valve implantation. I could find no disclaimer to this effect on their site.

US FDA regulations that clearly state that marketing experimental devices before they are properly labeled is strictly prohibited. But does that marketing scheme pertain to other companies that don't make those devices? I don't know. It is interesting that this app promotes doctors who are investigating some of the percutenous aotic valve devices to patients eager to "learn more." I'll let you decide if that sounds like marketing.

But alas, it's a new iPhone frontier and the information contained on the device is out there in other locations on the web. Feel free upload the 5+ megabyte app on your iPhone for "free" and look around at the pretty pictures and see the link under "Resources" to PubMed's home page or the blog with a few entries. While there are a few bugs in the software, it's interesting to see where things are going in mobile health care information age for patients and doctors.

It's also interesting to see the challenges industry will have going forward trying to comply with FDA marketing regulations.

Wednesday, October 21, 2009

In a sad case here in Chicago, it is interesting to note that a person's pacemaker can help identify them if no other means of identification exists following a homicide:

Ruby and Milton McClendon's bodies were discovered about 12:30 p.m. Monday in the Wentworth Woods of the Cook County Forest Preserve off Campbell Road between Pulaski and Michigan City Roads.

An autopsy performed Tuesday determined that Milton McClendon died from a gunshot wound to the head and Ruby McClendon died from multiple gunshot wounds. Milton McClendon, who was identified through his heart pacemaker, was 78, and his wife was 76, records show.

This is not the first time pacemakers have been used to determine critical identifying information or details (subscription) about the time of death. All patients implanted with medical devices (especially pacemakers and defibrillators) are followed by tagging the serial number in the device in the rare event that device advisories require patient notification.

Wow, some choice words on the Senate floor from Tennessee Republican Senator Bob Corker yesterday on the Hill:

We all know that the selling of one’s body is one of the oldest businesses that has existed in the history of the world. And so the AMA now is engaged in basically selling the support of its body by throwing future generations under the bus by in essence urging that we as Congress pass this week a quarter of a trillion spending bill, unpaid for. And if we would do that we might get their support in health care reform.

In all seriousness, the mashinations going on the Hill often leave me perplexed. Fortunately, all one has to do in such a situation is turn to a fellow cardiac electrophysiologist to help explain things, and no one does it better than Dr. Rich over at the Covert Rationing blog:

Furthermore, the Democrats have to find a way to pay for their healthcare reforms without alienating some of their key constituencies. Reforming healthcare will be so supremely expensive that it will be utterly impossible to actually pay for it only by taking money from the rich. The Democrat reform plans that we know a little about reveal this problem. HR 3200, for instance, according to the CBO, explodes the federal deficit. And the Baucus plan introduces fees, penalties and surcharges that threaten to affect many if not most middle-class Americans (including, worst of all, members of labor unions with very nice health plans). To pass a bill, the Democratic leadership will have to sell the fiction that the whole thing can be paid for without causing any of their key constituencies any significant fiscal pain.

Perhaps the biggest problem of all is that with any healthcare reform “victory,” Democrats will have to take control of covert healthcare rationing. Covert rationing will be much more difficult for a government-run system than it has been for insurance companies. A government healthcare system will not have the opportunity to incorporate the most effective rationing techniques that have been available to the insurance industry - cherrypicking patients, for instance, or canceling the policies of people who get sick. Nor will the government be able to get away with summarily denying patients needed medical services - a standard tactic of HMOs. This is especially true now that chief Republican intellectuals have called everyone’s attention to the possibility of death panels. The unwashed masses, having been duly alerted to the government’s intentions of withholding life-saving healthcare, will now be on the lookout for “unreasonable” denials of care. Any move by the government to refuse to pay for a particular medical service will have to be supported by extremely convincing clinical data (which itself will be very expensive to collect), and even then Americans may not quietly accept such denials. The “death panel watchdogs” will be alert for every move the government makes, and will be quick to howl an alarm.

So even though the Democrats are in complete control of the process - the only people they have to convince to vote for reform being other Democrats - and even though they have the insurance industry in their pocket (unless they continue to alienate them by reneging on deals), assembling a reform plan that Congress will pass remains a huge challenge.

In summary then, if the AMA is the fiscally irresponsible prostitute, then Congress is their pimp.

Monday, October 19, 2009

It seems the Congressional Budget Office's prediction of the cost of the Baucus bill, some $829 billion dollars, was only achieved by removing Congress's pledge to abolish the "sustainable growth rate" adjustment for physician pay, saving the bill some $200-240 billion dollars in costs over 10 years. Instead, this portion of the health care legislation was carved out and placed under a separate bill, S. 1776 as an "accounting trick."

Lord knows how many other pieces of legislation have been similarly extracted from the original health reform bill for budgetary expediency.

Sunday, October 18, 2009

On Wednesday, the Alliance of Specialty Medicine (the Society is an active member of the Alliance), as well as the American Medical Association and nine other medical societies attended a meeting with the following officials: Senate Majority Leader Harry Reid (D-NV), Senate Finance Committee Chairman Max Baucus (D-MT), Senate Health Committee Member Chris Dodd (D-CT), White House Chief of Staff Rahm Emanuel and Office of Health Reform Director Nancy-Ann DeParle. During the meeting it was announced that S.1776 will serve as the Senate vehicle for eliminating the SGR formula and lay the foundation for establishing a new Medicare physician payment system. This new proposal will be incorporated into broader health care reform legislation.

The Society encourages Senators to support S.1776 as an important first step toward the establishment of a stable physician update mechanism. However, the details of this new system have not been determined. (emphasis mine)

The Senate is expected to start voting on S.1776 as early as Monday evening. The Senate will vote four times. Following Senate rules, the first three votes will be procedural requiring 60 votes. The Senate will then vote for passage of the SGR repeal bill, which requires only 51 votes. In exchange for repeal of the SGR formula, the Senate Leadership has asked physician groups to support health care reform legislation that is currently moving through the Senate.

While the Society supports the repeal of the SGR formula, we are concerned with several other provisions proposed in the Senate Finance Committee health care reform legislation, such as mandatory pay for performance, payments cuts to physicians who exceed resource use benchmarks, preferential payment for primary care and placing payment system decisions in the hands of a new Medicare Commission composed of 15 unelected individuals.(emphasis mine, again)

I would favor letting the SGR formula cuts go through and let Congress deal with the consequences. The other "deals" they want in return for abolishing the SGR payment formula are more concerning to me in the long run.

I had an interesting visit with the husband of my niece last evening. He works as an ER doctor that is self-insured group of 60 physicians that cover the ER needs of four hospitals in Clark County near Las Vegas.

What is interesting is they are self-insured to save costs. As a group, then, they know how much per patient they must collect to assure liability care for every patient that comes to their emergency rooms.

That amount is $17 per patient per visit.

Guess how much their group receives for care they render to a Medicaid patient for a "level two" visit (minor problem: ear ache, sore throat, etc.)

Fourteen dollars per visit.

(Note: Medicare level two patients pay considerably better (about four times as much)).

When liability costs exceed the payments received for the care provided to those most in need, it's interesting that our legal and political forces in Washington see no need for liability reform as part of our larger health care reform efforts underway.

Real reform won't happen until the American people take their seat at the head of the table and invite doctors, ethicists and healthcare experts (not industry lobbyists) to bring their best knowledge about what interventions are most important, most effective and most cost efficient. Then we can sort out our priorities (you can call it rationing if you want) and create a budget.

Only then we can begin to negotiate with third parties (insurers, Big Pharma, etc) to sell us what we need at the best price. That's called competition, and it's what American capitalism is all about, right?

The problem is, the American healthcare consumer (and I include myself here) still thinks someone else is footing the bill. Who that someone is, I don't know. Maybe the rich. Maybe our employers. Maybe the Federal Government.

What we have yet to get is that there is no "someone else". The deep pockets are our own pockets, and they are empty. Our tax dollars. Our pensions. Our companies going bankrupt from paying employee health care costs.

Until the American people get it that it is our responsibility to get our spending in line, and until our representatives have the guts to turn away the industry lobbyists and represent their constituents instead of their campaign bankrollers, we will continue to have uncontrolled health care spending.

Friday, October 16, 2009

... Kim has a nice run-down on what I've been up to over at Emergiblog. Yesterday's conference on medical blogging and the impact that social media will play in the future direction of health care was fascinating and well worth the trip. Issues discussed were far-reaching, including the legal issues facing physician and nurse bloggers, what new media means to hospital and the medical device/pharmaceutical industries, and the impact/influence medical bloggers can have upon mainstream media and patient communication.

Everyone had a great time and I would encourage anyone out there with an interest in this venue to join us next year!

Wednesday, October 14, 2009

"The link between erectile dysfunction and coronary artery disease has been well established. Based on this evidence, we are investigating the use of stents in pelvic arteries to determine whether it may provide a new treatment approach and enable better response to drug therapies"...

Tuesday, October 13, 2009

So let me get this straight. The government sets the rates for the poor and disadvantaged and one of the President's model health care systems balks? How's this going to work when the government runs more and more of the health care delivery in the US?

It came in the mail to one of my partner's patients, a direct mailing (4 pgs, pdf, 1.2M) promising cheap drugs at significant cost savings from Global Pharmacy Canada. A closer look at the flier, however, discloses the drugs are not from Canada, but rather pharmacies somewhere in India.

Call it global direct-to-consumer pharmaceutical advertising. All you have to do is sign a little waiver and send your money:

I appoint Global Pharmacy Canada to act as my agent to send my order and prescriptions to a licensed pharmacy in India, so that the pharmacy can send my medications directly to me. I understand that my prescriptions will be filled according to the laws of India, as defined by India's FDA. By completing and signing this form, I understand that I am placing an order for generic medications to be shipped from India. I understand I am not relying on Global Pharmacy Canada for any health-related counseling. The medications ordered on this form have been prescribed by a licensed medical practitioner and I am relying on him/her for all medical advice relating to the use of these medications.

At a time when seniors are increasingly taxed by high drug costs and Medicare's "doughnut hole," these fliers are filing our patients' mailboxes. As the world is increasingly becoming a global medical marketplace, it is not surprising to find these marketing tactics by well-organized challengers arriving directly to our patients by any means possible.

For doctors, the ramification of this is significant. Historically, US physicians have enjoyed a relatively safe pharmaceutical marketplace, thanks to regulators and pharmacists. Because of the internet, pharmacists are becoming irrelevant to patients and the challenges of policing global pharmaceutical manufacturing and packaging operations has been difficult for the US Food and Drug Administration. One only has to recall the recent heparin recall to understand the far-reaching implications of this reality for doctors, especially in the age of generic medications. Now, not only will we have to know the name, dose and amount of the drug a patient is taking, we'll have to know where it was manufactured. The need for monitoring the origin of individual pills has not been lost on the pharmaceutical industry as they consider means to label pills with ingestible RF id tags.

It is any one's guess about the safety and efficacy of the Indian pharmacies co-oped by Global Pharmacy Canada, since the patient is not privy to the location or name of the pharmacy or pharmacies utilized. While I have no idea of the legitimacy or safety of Global Canadian Pharmacy, it appears the Canadian government is quite accustomed to these marketing practices, at least on the internet:

Buying drugs from Internet pharmacies that do not provide a street address and telephone number may pose serious health risks. You have no way of knowing where these companies are located, where they get their drugs, what is in their drugs, or how to reach them if there is a problem. If you order from these sites, you may get counterfeit drugs with no active ingredients, drugs with the wrong ingredients, drugs with dangerous additives, or drugs past their expiry date. Even if these drugs do not harm you directly or immediately, your condition may get worse without effective treatment.

While problems with generic drug manufacturers from India are not new (see here and here), doctors must realize that patients desperate to find affordable alternatives to their high drug prices will be vulnerable.

The same concern of these cheep overseas drugs goes for our pets, too. I find it concerning that Global Pharmacy Canada also advertises the sale of pet medications on the same flier. Melamine-contaminated pet foods are in our recent past, and the thought of such a contaminant in human drugs would make the diagnostic challenge for physicians rival any episode of House.

What is clear for the US pharmaceutical industry is that their pricing structure makes them vulnerable to disruption by the global marketplace. If quality and safety issues are overcome by these overseas pharmacies, the proverbial health care cost curve that Congress has found so elusive to bend, will soon be bent in the patient's favor.

For now, however, for those who decide to proceed with the purchase of drugs from these direct-to-consumer pharmaceutical fronts, caveat emptor.

Monday, October 12, 2009

Every cardiac electrophysiologist has been there: a relatively young individual in their 50’s presents to the Emergency Room short of breath, sitting bolt upright in bed and is found to be in congestive heart failure. This is not their first admission; several others have come before and each with a common theme: a positive urinary screen for cocaine.

The EKG shows left bundle branch block. Catheterizations occur, coronary disease absent or moderate, discussions held, patient recommended for defibrillator or biventricular pacing to improve their heart failure after medications have been ineffective for the past year. The person seems sincere – “No more drugs, doc, really” – a line uttered near the conclusion of every one of the patient’s prior hospitalizations, but this time, really, they mean it.

I wrestle with the ethics of the management of these patients every time I’m called to see them. Our guidelines state that ejection fractions of 15% should be treated with defibrillators, especially if no improvement on adequate, aggressive medical therapy. Our guidelines also say that patients with significant social or psychological disease that precludes careful follow-up of their device should not get a defibrillator. Outside the room the decision seems obvious; inside the room after a glance at the eyes of the desperate its another thing entirely - the suffocating feeling of heart failure having taken its toll. The family, at the patient's side, is concerned and wants to help, wondering if there’s anything that can be done.

Will the patient really quit using cocaine? My father’s voice whispers in my head: “What a person has done is an indication of what they will do.” Our business manager wonders why our volumes have slipped recently. What if they die shortly after leaving the hospital suddenly?

No matter what I decide, I will fail it seems. Is the patient sincere or playing me the fool? Can I tell? Put in the defibrillator or pacemaker perhaps it will help. But if I have guessed wrong, then resources are wasted and the patient is exposed to another risk, like infection. Don’t put in the defibrillator and I revoke a lifeline or effective therapy.

On the surface, these decisions should be easy. In reality, they are anything but.

Friday, October 09, 2009

Fellow cardiac electrophysiologist Leslie Saxon, MD thinks patients should own their medical device information in the era of "body computing:"

But there are major obstacles standing in the way of people's rights to access their health care data. There are over 400,000 patients with implanted defibrillators that have networked capability. Up to 20 percent of people with defibrillators will be shocked from the device. While the shock is life-saving and one of the main reasons the device gets placed, patients feel something that is akin to a punch in the chest and it causes great concern and curiosity from the patient. Where does the vital information about the shock go?

It is transmitted to a secure server--managed by device manufacturers--and the information is then downloaded to a secure web site for the patient's physician. I think patients have a right to see the information, and be able to share it with family members and other physicians, but patients are given no opportunity to access it. Device manufactures tell me that they won't allow patients to access the data because they are worried about insulting the physician who implanted the device. Physicians aren't exactly excited to give up the data because they believe it will cause more work and put them at risk for lawsuits.

So what are those "major obstacles" to allowing patients access to their health information?

Privacy and Safety

You can never be too careful with health information - especially if its yours. Powerful governmental rules exist to make sure your cannot access your health information easily. In 1996, with the advent of electronic submission of claims to the US government, concerns over the privacy of electronically-encoded information surfaced and resulted in the development of HIPAA, enforced by the governmental Office of Civil Rights. After the Institute of Medicine's "landmark report" entitled "To Err is Human: Building a Safer Health System," (available for purchase only) which highlighted critical areas of research and activities needed to improve the safety and quality of health care delivery, Congress passed the Patient Safety and Quality Improvement Act of 2005 (PSQIA). PSQIA provides Federal privilege and confidentiality protections for patient safety information called "patient safety work product." Patient safety work product includes information collected and created during the reporting and analysis of patient safety events. These safety events then feed into the Agency for Healthcare Research and Quality (AHRQ) which has responsibility for listing patient safety organizations (PSOs), the external experts established by the Patient Safety Act to collect and analyze patient safety information. Who are Patient Safety Organizations? Well there's one for nearly every state. The data collected from these PSO's feed into a carefully contructed Network of Patient Safety Databases (NPSD). These NPSD's will receive, analyze, and report on de-identified and aggregated patient safety event information with the goal of facilitating aggregation and analyses of patient safety event information to help reduce adverse events and improve health care quality. All of this aggregated information is then protected by the PSO Privacy Protection Center.

Despite all of the above safety and privacy safeguards, legal liability concerns loom large in the minds of health care providers and device manufacturers as violation of privacy laws can lead to jail time and hefty fines. With the increasing need to balance governmental budgets, we're seeing an increase in audits of health information, thanks, in part to the Health Information Technology for Economic and Clinical Health Act (HITECH Act):

American Recovery and Reinvestment Act of 2009 (ARRA) also includes a section that expands the reach of the Health Insurance Portability and Accountability Act (HIPAA) and introduces the first federally mandated data breach notification requirement.

Title XIII of ARRA, also known as the Health Information Technology for Economic and Clinical Health Act (HITECH Act), reserves $22 billion to "advance the use of health information technology" -- in large part so the U.S. will be able to move to e-health records by President Obama's 2014 deadline.

It also expands the reach of HIPAA data privacy and security requirements to include the "business associates" of those entities (health care providers, pharmacies, and the like) that are subject to HIPAA.

This act significantly expands the reach of the HIPAA Privacy Rule and Security Rule, along with the corresponding penalties. Subsection 13410(c) requires civil penalties that are collected under the HITECH Act to be funneled back into the Department of Health and Human Services' Office of Civil Rights enforcement budget, completing the funding "Circle of Life" for the system.

So if you're wondering why you can't get your health information I think it's pretty clear...

... might help some university hospitals get a jump on the competition, courtesy of an NIH grant:

Aided by a $4.5 million grant from the National Institutes of Health, the two universities are expected to immediately launch joint clinical programs to treat heart disease, based at both Yale-New Haven Hospital and (University College-London) UCL-affiliated hospitals.

While Yale has thousands of international partnerships, the scale of the new collaboration and the linking of two extensive hospital complexes is unique, Yale President Richard C. Levin said Thursday.

* * *

The joint effort is expected to create a “test bed for analysis of various clinical procedures,” Levin said, noting the partnership could eventually extend beyond cardiology, and would give Yale access to extensive British data systems.

Medical devices often receive approval in the United Kingdom before they are approved in the U.S. The partnership will enable Yale to study innovative drugs before they are available in the U.S., Levin noted.

“We can be immediate adapters on the frontier of medical innovation,” he said.

Look for increased pressure on universities to forge such collaborations in Europe as the regulatory environment in the U.S. becomes increasingly hostile to researchers.

In 2008, Lebônê (the word means “light stick” in southern Africa’s Sotho language) field-tested its first prototype in Tanzania, the home country of team member Stephen Lwendo. Simple and cheap, the (microbial fuel cell) MFC came in a 5-gallon bucket. It consisted of a graphite-cloth anode, a chicken-wire cathode, manure-rich mud for fuel, a layer of sand to act as an ion barrier and salt water as an electrolyte—all attached to an electronic power-management board. In June 2009, team members traveled to Namibia to launch a pilot program featuring 100 MFCs made from small canvas bags that can be linked for increased voltage. The bags are filled with dirt and buried. When watered to keep the microbes munching, the buried cells can produce power for months.

Thursday, October 08, 2009

Patients who received refurbished pacemakers donated from Detroit area funeral homes survived without complications from the devices, according to a case series reported by the University of Michigan Cardiovascular Center.

The pacemakers were implanted in 12 patients at the University of Philippines- Philippine General Hospital who could not afford advanced cardiac care and were confined to their beds as they waited for a permanent pacemaker.

It seems a clinical trial might occur to test the safety of using used pacemakers here in the US:

In the next phase, the U-M Cardiovascular Center will seek approval from the U.S. Food and Drug Administration to embark on a large scale clinical trial to show that pacemaker reuse is safe and effective.

It'll be interesting to see how the enrollment in such a trial proceeds. I suspect it might be a bit rough as long as the devices are covered by peoples' insurance.

There once was an Emperor of a prosperous country who cared more about health care costs than military pursuits or unemployment so he requested accountants provide him the finest cost estimates as he undertook health care reform.

This cost estimate, they tell him, will be to three significant digits and will account for all potential changes to the world that might occur for the next ten years, but because of how they were derived, will be invisible to anyone who was either stupid or unfit for their position.

The Emperor pretends that he understands the accuracy of the estimates so as not to appear stupid; his ministers do the same. When the accountants report that the cost estimate that was generated in record time and includes provisions for hundreds of amendments just passed, they arrive and mime a beautiful robe of cost estimates. The Emperor then goes on a procession through the Capital showing off his new "clothes".

During the course of the procession, a small doctor cries out, "the Emperor is naked!" The crowd realizes the doctor is telling the truth when they realize no one has any idea how much anything really costs in health care. The Emperor, however, holds his head high and continues the procession.

The two-time Oscar winner announced on Twitter today that she's checking into a hospital for a heart procedure. But don't worry—she predicts she'll be back on her feet in no time.

"[The procedure is] very new and involves repairing my leaky valve using a clip device, without open heart surgery, so that my heart will function better," tweeted Taylor.

"Any prayers you happen to have lying around I would dearly appreciate. I'll let you know when it's all over. Love you, Elizabeth."

The initial EVEREST I trial reported in the Journal of the American College of Cardiology on the first 24 patients receiving the device showed four 30-day major adverse events: partial clip detachment in three patients, who underwent elective valve surgery, and one patient with post-procedure stroke that resolved at one month. Three additional patients had surgery for unresolved MR, leaving 18 patients free from surgery.

More recent data on 107 patients in the US are summarized in a company press report and reported at this year's Transcatheter Cardiovascular Theraputics conference suggest favorable results with seventy-four percent of patients achieved MR reduction to 2+ or less and in 64 percent of these, MR reduction to 1+ was achieved. Additionally, there were no cases of clip embolization or procedural mortality reported. Kaplan-Meier freedom from surgery was 88.5%, 83.2% and 76.3% at 1, 2 and 3 years, respectively.

... over at the excellent Pallimed: A Hospice and Palliative Medicine blog:

Welcome to Grand Rounds, a weekly round-up of the best of the medical blogosphere. We here at Pallimed (Drew, Lyle, Amy, Amber and myself) are honored to be hosting Grand Rounds for the 3rd time. For the history books here are the 2007 (theme: prognostication) and 2008 editions. The theme this week is "The Art of Medicine and Nursing" in honor of our sister blog Pallimed: Arts and Humanities.

After the botched Presidential photo-op yesterday to promote the government's unprecedented intrusion into the doctor-patient relationship, I wonder if the President is aware of the latest thinking on white coats and that England has proceeded to ban them.

Ah, but no matter. It's better living through bureaucracy and politics...

Take a provision in the Baucus bill that would punish any physician whose "resource use" is considered too high. Beginning in 2015, Medicare would rank doctors against their peers based on how much they cost the program—and then automatically cut all payments by 5% to anyone who falls into the 90th percentile or above. In practice, this rule will only apply to specialists.

Since there will always be a missing chair when the music stops, every year one of 10 physicians will be punished if he orders too many tests, performs too many procedures or prescribes too many drugs—whether or not the treatments result in better patient outcomes. The 5% fine is substantial given that Medicare's price controls already pay only 83 cents on the private dollar.

In Medicare, meanwhile, the Administration is using regulation to change how doctors are paid to benefit general practitioners, internists and family physicians. In next year's fee schedule, they'll see higher payments on the order of 6% to 8%. The loose consensus is that the U.S. does have too few primary care doctors—less than 5% of medical students are entering the field—in part because they're underpaid.

Fair enough. But this boost for GPs comes at the expense of certain specialties. The 2010 rules, which will be finalized next month, visit an 11% overall cut on cardiology and 19% on radiation oncology. They're targets only because of cost: Two-thirds of morbidity or mortality among Medicare patients owes to cancer or heart disease.

. . .

One priority of the Baucus bill is to require the executive branch to wreak this kind of devastation every year, not just when a Democrat is President. It directs the Secretary of Health and Human Services to search out "potentially misvalued" RVUs, meaning those "for which there has been the fastest growth" or "that have experienced substantial changes in practice expenses." In other words, any specialty that grows too much must be targeted.

It's important to understand that these are "cuts" that don't actually cut any spending; the RVUs merely redistribute it from one medical bucket to another. In this case, Team Obama is sending a message to the medical community about its political priorities. The fee schedule is designed to avoid wild year-over-year payment swings, but HHS justified its decision with a flimsy survey whose data it won't release and whose results can't be replicated. (The President of the American College of Cardiology) Dr. Lewin told us that both HHS Secretary Kathleen Sebelius and budget director Peter Orszag refuse to meet with him to discuss the topic.

It'll be interesting to see how this all plays out. In the end, as dollars get pushed upstream to primary care physicians in favor of specialists and our older, experienced specialists retire, I wonder if the push to specialization will be as strong, leaving our seniors most affected by this policy. Yet, ironically, when the bean counters tally the health care cost tab at the end of the day, our policy makers will feel completely vindicated.

After all, it's our seniors who drive most of the cost for health care anyway and in the game of monetary musical chairs, someone has to ultimately sit out.

Monday, October 05, 2009

A 61-year-old male presented to the emergency room with a gunshot wound to the upper left chest. He had a history of myocardial infarction, two coronary bypass graft surgeries, and intracoronary stents. The patient had chronic ischemic cardiomyopathy with a left ventricular ejection fraction of 24%. He received a Medtronic Virtuoso-DR D154AWG (Minneapolis, MN) transvenous implantable cardioverter-defibrillator (ICD) in 2007 for primary prophylaxis. Since implantation, he had never received ICD therapy but did atrial pace frequently. The ICD had been interrogated 2 weeks prior and was found to function normally. Despite the gunshot wound with an entry to the chest located just medial to the ICD generator, the patient remained alert with stable vital signs and virtually no symptoms.

Pairing of improper complaint codes with legal proceeding codes will result in non-payment. “Up-coding” of legal proceedings shall constitute grounds for prosecution with some additional fines imposed by the IRS, as determined by the Office of Health and Human Services. For instance, pairing a legal complaint of “Spilling, Coffee, Hot, with blisters” to and of those of Divorce, same gender, living apart, male (or female) (shown below) will result in non-payment.

In the past, hospitals hired primarily family doctors who would refer patients to the facility for medical tests. Now, hospitals are employing more specialists.

For example, having a neurologist or cardiologist on staff allows quicker patient consults than waiting for a private-practice doctor to come to the hospital.

"The reason we even employ specialists is to provide inpatient coverage on our floors in the hospital," said Cindy Sheets, senior vice president ambulatory services for Mount Carmel Health System.

Another reason specialists are consolidating with hospital systems is the high cost of bringing on other experienced specialists that have insurance "tails" from their former practice. These insurance "tails" assure continued malpractice insurance coverage on patients from their former practice as they start employment (and new malpractice insurance coverage) with their new group.

Not only do doctors need portability of their own health insurance from one job to the next, they need portability of their malpractice insurance, too.

Friday, October 02, 2009

I just finished our first day at the Principle Investigator Meeting for the launch of the Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial in Philadelphia today. The trial is a 3000-patient patient trial performed at 140 centers around the world and jointly sponsored by the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH), and industry (St. Jude Medical and Biosense Webster).

The trial will randomize 3000 previously untreated or incompletely treated patients at high risk of cardiovascular complications in the trial to two arms: 1500 patients to catheter ablation as primary therapy of atrial fibrillation and the other 1500 patients to conventional medical therapy with rate control or rhythm control strategies to determine if catheter ablation is superior to medical therapy at reducing total mortality (the primary endpoint). Secondary endpoints of a composite endpoint of mortality, disabling stroke, serious bleeding, or cardiac arrest will also be studied.

If done properly, this study stands to be a landmark trial for the field of cardiac electrophysiology and has huge ramifications for the treatment of patients with atrial fibrillation. Also, it doesn't take a lot of rocket science to know that the government will be looking closely at the results of this trial to determine which treatment strategy will receive government funding.

With our current climate of health care reform, one would think that this is the kind of trial the government would want to fund and fund well. After all, the Institute of Medicine labeled (pdf) the treatment of atrial fibrillation it's number one "priority topic" to study.

But the truth is: this trial never would have seen the light of day if it weren't for industry. Note that St. Jude Medical paid $20 million and Biosense Webster paid $18 million toward the trial, while the government could only foot 35% ($18 million) of the costs for the trial. Some will consider this an "efficient" use of government funds. Others will point to the government's new paradigm for requiring significant industry sponsorship to fund their comparative effectiveness research (CER) trials as opening the potential for the development of "pay to play" relationships to develop between government and industry. One only has to look to the FDA's recent challenges at separating themselves from industry influence to see the potential for conflict.

Further, despite the government's enthusiasm to proceed with CER of this fashion, every investigator I spoke with today, without exception, felt the project grossly underestimated the costs required to perform the study at their center. While this will certainly delay enrollment of patients into this trial, it also serves as a harbinger for the penurious nature of future government funding for comparative effectiveness research.

Thursday, October 01, 2009

It's been very crazy clinically this week, and I'm soon to head off to Philly for the CABANA trial investigator meeting, but I wanted to share a few key links before I left:

First, Change of Shift, the best posts of the week from our nurses is up over at Emergiblog.

Next, Paul Levy, President and CEO of Beth Israel Deaconess hospital has a nice series of videos covering the culture of safety and how their hospital is making their safety data transparent, using patient advocates, and how patients there keep in touch with friends and family. Good stuff. Just try to look past the J&J ads.

Finally, if you haven't done it yet, shoot over to Medgadget to vote for who you think will be the next nobel prize recipients.

The heart is an amazing organ - incredibly strong as it beats over 31 million times a year while generating enough pressure to eject a column of blood over 5 feet high with each beat, yet incredibly fragile as it can degenerate into a quivering, disorganized lump of muscle with little more than the current from a 9-volt battery.

We've all done it at one time or another: touched a 9-volt battery to our tongue. If that little tingling sensation on the tongue is strong enough, well then, there's probably enough power left in the battery to use it in a smoke detector or transistor radio.

But there is probably enough energy remaining to fibrillate the heart, too. Fortunately for those lingual testers, the not enough energy passes toward the heart as the electrons flow between the closely-approximated poles of the battery as it touches the tongue.

But if there were a wire connected to the heart and the battery passes current to the heart via the wire, ventricular fibrillation ensues as the cells in the heart reach threshold and fire in an uncoordinated fashion, causing the pumping to cease as the wondrous muscle to quiver erratically.

It only takes 1 milliamp of current applied for a sufficiently long period of time (seconds) for the myocardial cells to reach threshold and fire haphazardly, creating ventricular fibrillation. For medical students and residents, the thought of inducing a fatal arrhythmia with something as simple as a 1.5 volt or 9-volt battery seems almost unreal, until they see it in person.

Sometimes in my field there is a need for inducing ventricular fibrillation. Now before people think I've completely lost my senses, realize that cardiac electrophysiologists induce ventricular fibrillation nearly every time they implant a cardiac defibrillator (ICD) to assure the device will properly detect, charge, and restore a patient's heart rhythm in a carefully controlled setting with the patient sedated. This procedure was particularly important in the nascent days of ICDs that were not as efficient at restoring normal rhythm as they are today. Still, it is estimated that a little more than 5% of initially-implanted defibrillator systems will have unacceptably high energy requirements with their initial lead configurations to assure proper cardiac defibrillation. So with proper backup defibrillation capabilities, patient selection and special safety precautions, defibrillator testing (that is, inducing ventricular fibrillation in a controlled setting to confirm that the ICD will function properly) is usually performed at the time of ICD implant. If excessive energies are required to restore the heart rhythm to normal, electrophysiologists reposition or add additional shocking electrodes to achieve acceptable defibrillation energies before the patient leaves the laboratory.

On very rare occasions, however, the conventional means of inducing ventricular fibrillation during ICD testing proves unsuccessful. In those rare cases, electrophysiologists often reach for a 9-volt battery to induce the abnormal heart rhythm to permit defibrillator testing. Suffice it to say, the amount of current required to achieve such a feat is remarkably small and it is almost always successful when other modalities fail. It is no accident that special electrical grounding and isolation circuits are built into all electrophysiology laboratories to avoid even the smallest of current leaks that might cause inadvertant induction of ventricular fibrillation. After all, nowhere are wires touching the heart more than in our laboratories.

People often wonder how electrophysiologists can apply any electrical energy directly to the heart without fibrillating it as we burn (cauterize) tissue during catheter ablation procedures. The answer is by administering a very high frequency of energy: low frequencies permit enough time for the cells to reach threshold, while very high frequencies render the heart effectively "blind" to the energy delivered. This is why electrophysiologists apply alternating current of 500,000 Hertz (500 kHz, or "500 on your AM dial") rather than the much slower frequency of energy (60Hz) that leaves our wall sockets or even the low-energy direct current that leaves a common 9-volt battery.

Finally, no discussion would be complete without describing the defibrillation of the heart (converting the heart back to normal rhythm). To achieve this, ICD's typically apply a very strong 35-joule (830-volt direct current) shock in about a tenth of a second across the fibrillating heart muscle to hyperpolarize all of the cell membranes briefly and disrupt the chaotic activation of the quivering heart muscle. External defibrillators usually apply 10 times that amount of energy (360 Joules) to overcome the resistance of the chest wall and lungs to current flow. If performed soon after the onset of the rhythm, this often results in restoration of normal rhythm and the subsequent resumption of normal cardiac contractions. If not, metabolic derangements make successful defibrillation increasingly difficult. The very short time to defibrillation is probably why ICDs are so effective at restoring rhythms to normal compared to external defibrillators.

About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.